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Complete Clinical Results of Phase I/II Studies with AP 12009 for Glioma will be presented at 2003 Annual Meeting of ASCO


Posted on: 05/21/2003

Press Release 2003/05/16

Complete Clinical Results of Phase I/II Studies with AP 12009 for Glioma will be presented at 2003 Annual Meeting of ASCO

REGENSBURG, GERMANY - May 16th, 2003. Antisense Pharma GmbH will present positive results from three Phase I/II clinical trials of AP 12009 at the 39th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, U.S.A.

May 31st - June 3rd 2003.

The complete results of the first two studies and preliminary data of the third study will be presented on Sunday, June 1st, 2003, 2:00 P.M. - 5:30 P.M., in Session GP19 ‘Central Nervous System’, Abstract ID #436, Poster Board J5 by Dr. Gerhard Stauder, Chief Scientific Officer of Antisense Pharma GmbH .

In the first phase I/II dose escalation study, 18 patients with high-grade glioma had been treated intratumorally with a single course of the TGF-b2 antisense phosphorothioate oligonucleotide AP 12009. In a second study, 2 patients received a second course of AP 12009. In a third study, up to ten courses of AP 12009 were applied to 7 patients. AP 12009 demonstrated an excellent safety and tolerability in all clinical phase I/II studies. The concentration had been scalated 113-fold. The treatment was considered safe by both the coordinating investigator as well as the independent Data and Safety Monitoring Board (DSMB).

The secondary objective of the phase I/II studies was to collect efficacy data on AP 12009 by assessment of tumor size and survival times. Five of 18 patients had an objective stabilization after one course, one more patient after the second course. Another patient revealed a complete response after one course of AP 12009 without any other anti-tumor therapy. An update on the median overall survival time of the patients treated with AP 12009 will be given at the conference. Based on encouraging results in preclinics for further solid tumor entities and these findings of the phase I/II studies for high-grade glioma, Antisense Pharma GmbH is preparing clinical trials with AP 12009 for the treatment of pancreatic carcinoma.

Antisense Pharma GmbH is the leading European company in antisense drug development. The company focuses on anticancer therapeutics for treating especially malignant tumors.


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